We are heading into the final month of the third quarter, and this is traditionally when the quiet summer period starts to heat up again and we get some volatility across wider markets. Biotech is no different from its other commercial counterparts, and there are a number of key events slated for September that have the potential to inject some volatility into the companies they represent. Here are two early September catalysts worth keeping an eye on as potential upside drivers in small tech biotech.
Bioline RX Ltd (NASDAQ:BLRX)
Bioline reported its second quarter financials back on August 11, and alongside the numbers gave us an update as to the progress of its pipeline. One of the noteworthy elements of this update was the company reporting it is set to reprt the full set of data from its phase II refractory relapsed acute myeloid leukemia (AML) at the Society of Hematologic Oncology (SOHO) annual meeting, September 7-10, 2016, in Houston, Texas. The drug is the company’s lead oncology platform, and it’s a short synthetic peptide that functions as a high-affinity antagonist of CXCR4. CXCR4 is a chemokine receptor that plays a role in cell proliferation, growth, replication etc. and its inhibition is expected to play a role in reducing, or at least halting the progress of, tumor cell proliferation.
AML is a rapidly expanding market, expected to grown from circa $3340 million in 2014 to around $1 billion in 2024, and data indicative of efficacy in this trial will be a big push forward for what is currently a just $50 million company.
We don’t have the exact presentation time and date (aside from the above mentioned range) but we will likely get a press release ahead of the presentation so this is what we’re looking to for insight. If we find out the specifics, we’ll update accordingly.
CoLucid Pharmaceuticals Inc (NASDAQ:CLCD)
Net up, CoLucid. This is another small cap biotech, but rather than oncology, its primary target indication is pain management. Specifically, the company’s target is migraine pain, with a drug it’s calling lasmiditan. The drug is the first in a completely new class of migraine pain management candidates, called ditans. The MOA of these drugs aims to reduce pain without having any cardiovascular impact (current SOCs do) and so the company believes it can be beneficial for patients that might be susceptible to heart related AEs if exposed to current SOC. Lasmiditan works by selectively targeting a receptor called the 5‑HT1F receptor. It’s a receptor agonist, designed too upregulate the activity of the receptor and work on what’s called the trigeminal pathway to reduce migraine pain without eliciting vasoconstriction (migraine pain is caused by vasodilation, so a lot of the current care options are vasoconstrictors).
The drug is in a phase III right now, and topline is set to report during the week of September 5 this year. At latest, CoLucid expects to put out the topline on September 9.
This is another rapidly expanding market, expected to grow to $5.8 billion in the US and Europe, so there’s also lots of potential upside if the topline suggests the drug is effective. Cardiovascular adverse events are a real consideration in migraine sufferers, especially at the older end of the scale, so there’s a decent portion of the large and growing market for CoLucid to go at on approval. This one would be targeting a late 2017 approval if the upcoming data justifies a new drug application.
So there we go. Two releases that relate to small companies, but have the potential to have a large impact on the market capitalization of those in question.